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HIP

CompletedPhase 3Results posted

Hormone and Information Processing Study

Testosterone Supplementation in Men With MCI

Lead sponsor

University of Washington

Asset

Testosterone gel

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Age 60-90•Male

Primary endpoints

•Behavioral & Mood Measure•Cognitive Changes•Geriatric Depression Scale (GDS)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Nih1R01AG027156-01A2

Org study ID29975-A

NCT IDNCT00539305

NihR01AG027156

Timeline

Milestones

Study first posted2007-10-04estimated

Study start2009-07 (month precision)

Primary completion2011-07actual (month precision)

Study completion2012-05actual (month precision)

Last update posted2014-07-14estimated

Results first posted2014-07-14estimated

Assets

Drug assets

Testosterone gel

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Male 60-90 years of age

•Diagnosis of mild cognitive impairment (MCI)

•Low testosterone level

•Primary language is English

•Availability of an informant who knows the participant well enough to answer questions

•Stable medications for the previous 3 months

•Normal complete blood count (CBC), and no clinically significant blood chemistry

•American Urological Association (AUA) symptom score less than or equal to 19

•Body Mass Index (BMI) less than 33 and stable weight in the previous year

Exclusion criteria

•Prior history of prostate cancer or prostate specific antigen level greater than 4.0ng/ml

•Peripheral or vascular disease

•Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per day), or other substance abuse

•History of severe head injury (with loss of consciousness greater than 30 minutes)

•Significant neurological illness, such as Parkinson's disease, seizure disorder, multiple sclerosis, major stoke

•Smokes cigarettes

•Major psychiatric illness, such as schizophrenia or bipolar disorder

Prohibited Medications:

•Anti-convulsants

•Anti-psychotics

•Sedating antihistamines

•Sedative/hypnotics

•Benzodiazepines

•Hormone or testosterone regimens

•Gonadotropin-releasing hormone (GNRH) antagonists

•Flutamide

•Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Memory

Other (unclassified)

Memory

2 endpoints

Primary/protocol endpoint

Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test

Time frame:Baseline, 3 and 6 months

change from baseline, improvement

Primary/registry result

Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test

Time frame:Baseline, 3 and 6 months

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Treatment GroupBaselinen=9 Participants	6.2	1.1
Month 3 (Change from Baseline)n=9 Participants	2.3	0.9
Month 6 (Change from Baseline)n=9 Participants	0.9	0.9
Placebo GroupBaselinen=10 Participants	4.9	1.0
Month 3 (Change from Baseline)n=10 Participants	0.0	0.8
Month 6 (Change from Baseline)n=10 Participants	1.5	0.8

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Behavioral & Mood Measure: Profile of Mood States (POMS)

Time frame:Baseline, 3 and 6 months

change from baseline, improvement

Primary/protocol endpoint

Geriatric Depression Scale (GDS)

Time frame:Baseline, Month 3, Month 6

change from baseline, improvement

Primary/registry result

Behavioral & Mood Measure: Profile of Mood States (POMS)

Time frame:Baseline, 3 and 6 months

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Treatment GroupBaselinen=9 Participants	57.7	2.2
Month 3 (Change from Baseline)n=9 Participants	-4.5	2.8
Month 6 (Change from Baseline)n=9 Participants	1.9	2.7
Placebo GroupBaselinen=10 Participants	55.5	2.0
Month 3 (Change from Baseline)n=10 Participants	-0.1	2.4
Month 6 (Change from Baseline)n=10 Participants	-0.5	2.5

Primary/registry result

Geriatric Depression Scale (GDS)

Time frame:Baseline, Month 3, Month 6

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Treatment GroupBaselinen=9 Participants	7.2	1.3
Month 3 (Change from Baseline)n=9 Participants	0.7	1.5
Month 6 (Change from Baseline)n=9 Participants	-2.8	1.5
Placebo GroupBaselinen=10 Participants	4.1	1.2
Month 3 (Change from Baseline)n=10 Participants	2.3	1.3
Month 6 (Change from Baseline)n=10 Participants	2.7	2.3

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Short-Form Health Survey (SF-36)

Time frame:Baseline, Month 3, Month 6

change from baseline, improvement

Primary/registry result/low confidence

Short-Form Health Survey (SF-36)

Time frame:Baseline, Month 3, Month 6

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Treatment GroupBaselinen=9 Participants	70.7	10.4
Month 3 (Change from Baseline)n=9 Participants	15.0	9.4
Month 6 (Change from Baseline)n=9 Participants	6.4	8.6
Placebo GroupBaselinen=10 Participants	85.6	2.3
Month 3 (Change from Baseline)n=10 Participants	-3.8	6.4
Month 6 (Change from Baseline)n=10 Participants	-5.4	3.5

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.